ID

37802

Description

Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal ofSentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Death Table contains one record per PatID.1,2 When legacy data have conflicting reports, please make a local determination as to which to use. There is typically a 1-2 year lag in death registry data. Note: For efficiency death data is captured in 2 tables: Death: the record that characterizes the death date and source of that information Cause of Death: the cause(s) of death associated with the death record These 2 tables are linked by PatID. All Cause of Death records have a matching PatID in the Death Table. PatID is a pseudoidentifier with a consistent crosswalk to the true identifier retained by the source Data Partner. For analytical data sets requiring patient-level data, only the pseudoidentifier is used to link across all information belonging to a patient.

Link

www.sentinelsystem.org

Keywords

  1. 1/11/17 1/11/17 -
  2. 1/29/17 1/29/17 -
  3. 8/25/19 8/25/19 -
  4. 8/25/19 8/25/19 -
Copyright Holder

FDA's Sentinel Initiative

Uploaded on

August 25, 2019

DOI

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License

Creative Commons BY-NC-ND 3.0

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Sentinel Common Data Model Death

Sentinel Common Data Model Death

Death
Description

Death

Alias
UMLS CUI-1
C0011065
Patient ID
Description

Unique member identifier. Arbitrary person-level identifier. Used to link across tables. Note: PatID is a pseudoidentifier with a consistent crosswalk to the true identifier retained by the source Data Partner. For analytical data sets requiring patient-level data, only the pseudoidentifier is used to link across all information belonging to a patient.

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Death
Description

Date of Death

Data type

date

Alias
UMLS CUI [1]
C1148348
Imputed Date of Death
Description

When DeathDt is imputed, this variable indicates which parts of the date were imputed.

Data type

text

Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C0750572
Source of death information.
Description

Source of death information.

Data type

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1955348
UMLS CUI [1,3]
C0449416
Confidence
Description

Confidence that the patient drawn from the Source data represents the actual patient (contrasts with Confidence in the Cause of Death table).

Data type

text

Alias
UMLS CUI [1]
C1704726

Similar models

Sentinel Common Data Model Death

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Death
C0011065 (UMLS CUI-1)
PatID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
DeathDt
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Item
Imputed Date of Death
text
C1148348 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Code List
Imputed Date of Death
CL Item
Both month and day imputed (B)
CL Item
Day imputed (D)
CL Item
Month imputed (M)
CL Item
Not imputed (N)
Item
Source of death information.
text
C0011065 (UMLS CUI [1,1])
C1955348 (UMLS CUI [1,2])
C0449416 (UMLS CUI [1,3])
Code List
Source of death information.
CL Item
Other, locally defined (L)
CL Item
National Death Index (N)
CL Item
State Death files (S)
CL Item
Tumor data (T)
Item
Confidence
text
C1704726 (UMLS CUI [1])
Code List
Confidence
CL Item
Excellent (E)
CL Item
Fair (F)
CL Item
Poor (P)

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